Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-06-30

Brief Summary

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This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.

The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.

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Detailed Description

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The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.

Conditions

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Major Depressive Disorder Without Psychotic Features

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Asenapine 5-20 mg daily

Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability

Group Type EXPERIMENTAL

Asenapine 5-20 mg daily

Intervention Type DRUG

5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

Placebo 1-4 tablets daily

Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability

Group Type PLACEBO_COMPARATOR

Placebo 1-4 tablets daily

Intervention Type DRUG

One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID

Interventions

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Asenapine 5-20 mg daily

5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID

Intervention Type DRUG

Placebo 1-4 tablets daily

One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID

Intervention Type DRUG

Other Intervention Names

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SAPHRIS Placebo

Eligibility Criteria

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Inclusion Criteria

-130 male or female patients, 18-65 years of age, with:

1. DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by the Mini-International Neuro-psychiatric Interview (MINI)
2. MADRS total score \> 20, and item 1 (Apparent Sadness) score \> 2 at enrollment and randomization
3. Inadequate therapeutic response during their current depressive episode; an inadequate therapeutic response will be defined as continued depressive psychopathology (see criterion 2) following \> six weeks of therapy at adequate doses (according to the US label) of any non-tricyclic, non-MAOI antidepressant medication

Exclusion Criteria

1. Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to enrollment
2. DSM-IV Axis II diagnoses that significantly impact the current psychiatric status
3. Current MDD episode lasting \> 12 months
4. Electroconvulsive therapy within the preceding 6 months
5. Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior to enrollment
6. Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or dementia (MMSE \<24)
7. Risk of suicide as defined by MADRS item 10 score \> 4
8. Prior failure to respond to asenapine
9. Pregnancy or failure to use an acceptable form of birth control. Pregnancy as determined by serum pregnancy test at baseline
10. Hepatic impairment and history of low WBC, by medical history and interview.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No